Blood plasma giant CSL has confirmed the deal with the Australian government to produce the University of Queensland’s COVID-19 vaccine has been sealed, with the next stage of trials planned to start in December.
The $132 billion biotech told investors on Thursday morning it had signed off on the final agreement to produce 51 million doses of the University of Queensland (UQ) vaccine , known as V451, if it is successful. It said first participants in the phase 2b/3 trials of the product would be enrolled in December if progress went as expected.
CSL has previously confirmed its priorities are the production of the UQ “molecular clamp” vaccine and making doses of the University of Oxford/AstraZeneca vaccine if these products pass clinical trials.
While the Oxford product is currently in the phase 3 trial stage, the UQ vaccine is still in phase 1. The production deal means CSL will oversee late stage trials of the product and produce it at scale if successful. The company confirmed on Thursday the large scale phase 2b/3 trial was “almost ready” and would be a randomised, placebo-controlled trial across multiple countries and more than 100 research sites.
The first subject would be enrolled in December, with “the goal of completing recruitment by March 2021”, the company said.
Earlier this year CSL said rollout of the UQ vaccine could happen as soon as the middle of next year, subject to successful trials. The company said it was committed to ensuring the vaccine was safe and effective before rolling it out to market.
“Discussions have already commenced with the Therapeutic Goods Administration to ensure this goal is met,” the company said in a statement.
CSL also confirmed it has started talks with partner organisations to “assist with the production of further doses with the goal of providing further access to the vaccine” if it is successful.
The production agreement involves the federal government paying CSL for the “clinical and technical development” needed to prepare its sites for production.
The company has previously said given the risk associated with vaccine production it’s not clear what the financial impact of its vaccine projects will be.
“Given the considerable risk, cost and uncertainty associated with the development of these novel vaccines, it is too early to calculate with any certainty the financial impact on the company,” CSL said in a statement.
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Source: Thanks smh.com